ManaEZ Night Splint, Plantar Fasciitis, Small EZSPNT01-S

GUDID 00810113683126

Ideal for patients that need to stretch the Achilles Tendon or Plantar Fascia. Common indications are Plantar Fasciitis, Tight Achilles, Achilles Tendonitis, and conditions where dorsiflexing the foot is part of the rehabilitation protocol. Easy-to-apply universal left/right design available in 3 sizes.

Manamed, Inc.

Ankle/foot orthosis flexion adjustment device
Primary Device ID00810113683126
NIH Device Record Key8db2b1ac-f2da-458f-87af-a04d66d3b2dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameManaEZ Night Splint, Plantar Fasciitis, Small
Version Model NumberEZSPNT01-S
Catalog NumberEZSPNT01-S
Company DUNS084042331
Company NameManamed, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810113683126 [Primary]

FDA Product Code

ITWJoint, Ankle, External Brace

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-06
Device Publish Date2025-09-26

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